Items

Specification

Appearance

A white or almost white crystalline powder

Solubility

Freely soluble in water, in ethanol(96%) and in methanol

Identification

A:Infrared absorption spectrophotometry

B:The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with the reference solution

C: A violet colour develops

D:The identification is not valid unless a solution prepared in the same manner using naphazoline hydrochloride CRS instead of the substance to be examined shows a distinct bluish fluorescence.

E:It gives reaction (a) of chlorudes

Appearance of solution

Clear and not more intensely colored than reference solution Y6

Acidity or alkalinity

The solution is red, not more than 0.2ml of 0.01M sodium hydroxide is required to change the colour of the indicator to yellow.

Related substances

Impurity A: NMT 0.2%

Unspecified impurity: NMT 0.10%

Total of impurity: NMT0.5%

Loss on drying

Not more than 0.5%

Sulphated ash

Not more than 0.1%

Assay

99.0%~101.0%(dried substance)